Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media

Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study

Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.

Study Overview

• Status: Recruiting
• Conditions: Chronic Suppurative Otitis Media
• Intervention / Treatment: Device: S53P4 Bioactive glass

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Leij-Halfwerk, Msc, Ir; Phone Number: 0882506172; Email: Wetenschapsbureau@diakhuis.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3582KE
    • Recruiting
    • Diakonessenhuis
    • Contact: Leij-Halfwerk, Msc, Ir; Phone Number: 088-250 6172; Email: Wetenschapsbureau@diakhuis.nl
    • Principal Investigator: J.J. Quak, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients that underwent canal wall up or canal wall down mastoidectomy between 2010 and 2022 will be evaluated. Only cases that full-fill the in- and exclusion criteria will be selected. Patients will be stratified for whether they received mastoid obliteration or not.

Description

Inclusion Criteria:

• Suffering from CSOM, as indicated by otorrhea as main complaint preoperatively
• At least one year of follow-up, in order to asses the primary outcome
• Opacification of the mastoid air cells on preoperative CT-scans, as indication for mastoid involvement
• Canal wall up or canal wall down mastoidectomy
• Operated between 2010 and 2022

Exclusion Criteria:

• Patients suffering from middle ear cholesteatoma

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients that underwent mastoidectomy alone; This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM without mastoid obliteration
Patients that underwent mastoidectomy + mastoid obliteration; This is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM followed by obliteration of the mastoid cavity using S53P4 bioactive glass	Device: S53P4 Bioactive glass; Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients with a dry ear at one-year postoperatively	The number of cases that have a dry ear at the one-year postoperative out-patient visit. A dry ear is defined as Merchant grade 0 or 1 (No otorrhea or less than one period of otorrhea in the last three months, respectively). A wet ear, thus suffering from otorrhea, is defined as merchant grade 2 or 3 (intermittent more than once in last three months or continuous discharge, respectively). We compare the obliteration cohort to the non-obliteration cohort.	At 1-year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of cases with perforations of the tympanic membrane during follow-up	The number of cases that will develop a perforation of the tympanic membrane during follow-up We compare the obliteration cohort to the non-obliteration cohort.	Measured at 1-year postoperatively and 3-years postoperatively
The difference in air conduction postoperatively	The differences in air conduction postoperatively, as measured in the first audiometry postoperatively in decibel. We compare the obliteration cohort to the non-obliteration cohort.	First audiometry postoperatively, which is made at 6 months postoperatively
The number of cases which require revision surgery during follow-up	The number of cases which require revision surgery during follow-up, for either recurrent CSOM and other indications We compare the obliteration cohort to the non-obliteration cohort.	Measured at 3-years and 5-years postoperatively

Collaborators and Investigators

• Sponsor: Diakonessenhuis, Utrecht
• Investigators: Principal Investigator: J.J. Quak, MD, PhD, Diakonessenhuis, Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Otorhinolaryngologic Diseases; Ear Diseases; Infections; Otitis; Otitis Media; Suppuration; Otitis Media, Suppurative
• Other Study ID Numbers: 16-004-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No